Prescription drug · ANDA
Polymyxin B Sulfate and Trimethoprim NDC 68788-6927
Polymyxin b sulfate 10000 [USP'U]/mL; Trimethoprim sulfate 1 mg/mL · Solution · Ophthalmic · Preferred Pharmacetucials Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68788-6927-1 | 68788692701 | 10 mL in 1 BOTTLE, PLASTIC (68788-6927-1)Marketed from Mar 30, 2018 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Polymyxin B Sulfate and Trimethoprim
- Generic name (nonproprietary)
- polymyxin b sulfate and trimethoprim
- Active ingredients
- Polymyxin b sulfate — 10000 [USP'U]/mLTrimethoprim sulfate — 1 mg/mL
- Dosage form
- Solution
- Route
- Ophthalmic
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 064211
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2C8 Inhibitors (Mechanism)Dihydrofolate Reductase Inhibitors (Mechanism)Organic Cation Transporter 2 Inhibitors (Mechanism)Polymyxins (Chemical structure)
- Identifiers
- Product ID 68788-6927_0c567a5b-d508-4f09-8157-c98cc4a7fc94SPL ID 0c567a5b-d508-4f09-8157-c98cc4a7fc94SPL set ID 65293418-c6ad-43d8-948c-e1949c0afc31RxCUI 244967UNII 19371312D4, E377MF8EQ8
- Pharmacologic class
- Dihydrofolate Reductase Inhibitor Antibacterial; Polymyxin-class Antibacterial
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Ophthalmic products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N468788692701followed by a unit qualifier and the quantityPackage 68788-6927-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
INDICATIONS AND USAGE Polymyxin B Sulfate and Trimethoprim Ophthalmic Solution is indicated in the treatment of surface ocular bacterial infections, including acute bacterial conjunctivitis, and blepharoconjunctivitis, caused by susceptible strains of the following microorganisms: Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pneumoniae, Streptococcus viridans, Haemophilus influenzae and Pseudomonas aeruginosa. * *Efficacy for this organism in this organ system was studied in fewer than 10 infections.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 064211
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Polymyxin B Sulfate and Trimethoprim | Polymyxin b sulfate 10000 [USP'U]/mL; Trimethoprim sulfate 1 mg/mL | SolutionOphthalmic | Proficient Rx LP | 63187-834 |
| Polymyxin B Sulfate and Trimethoprim | Trimethoprim sulfate 1 mg/mL; Polymyxin b sulfate 10000 [USP'U]/mL | SolutionOphthalmic | NuCare Pharmaceuticals,Inc. | 68071-4103 |
| Polymyxin B Sulfate and Trimethoprim | Polymyxin b sulfate 10000 [USP'U]/mL; Trimethoprim sulfate 1 mg/mL | SolutionOphthalmic | REMEDYREPACK INC. | 70518-1735 |
| Polymyxin B Sulfate and Trimethoprim | Polymyxin b sulfate 10000 [USP'U]/mL; Trimethoprim sulfate 1 mg/mL | SolutionOphthalmic | Sandoz Inc | 61314-628 |
| Polymyxin B Sulfate and Trimethoprim | Polymyxin b sulfate 10000 [USP'U]/mL; Trimethoprim sulfate 1 mg/mL | SolutionOphthalmic | A-S Medication Solutions | 50090-2925 |